MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE

Catalog Number 300865

Device Problems Leak/Splash (1354); Air/Gas in Device (4062)

Patient Problems Low Blood Pressure/ Hypotension (1914); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that bd plastipak¿ 50ml concentric luer lock syringe experienced a case of leakage, and a case of air bubbles in the syringe.The following information was provided by the initial reporter: the service reports that the syringe has a leakage defect at the level of the barrel of the syringe, (the syringe is smooth and without visible defect).During use (treatment with nimotop administered continuously with an electric syringe pump), the label of the syringe (placed in the middle of the syringe) is wet and comes off.There was about 35ml of solution left in the syringe when this happened.Some air bubbles are also found in the tubing of the syringe, (neoline extension), connected to the patient.

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that bd plastipak¿ 50ml concentric luer lock syringe experienced a case of leakage, and a case of air bubbles in the syringe.The following information was provided by the initial reporter: the service reports that the syringe has a leakage defect at the level of the barrel of the syringe, (the syringe is smooth and without visible defect).During use (treatment with nimotop administered continuously with an electric syringe pump), the label of the syringe (placed in the middle of the syringe) is wet and comes off.There was about 35ml of solution left in the syringe when this happened.Some air bubbles are also found in the tubing of the syringe, (neoline extension), connected to the patient.

Manufacturer Narrative

The following information has been updated due to corrected information: h.6.Imdrf annex e grid: e2321 - low blood pressure/ hypotension.H.6.Imdrf annex f grid: f24 insufficient information.

Event Description

It was reported that bd plastipak¿ 50ml concentric luer lock syringe experienced a case of leakage, and a case of air bubbles in the syringe.The following information was provided by the initial reporter: the service reports that the syringe has a leakage defect at the level of the barrel of the syringe, (the syringe is smooth and without visible defect).During use (treatment with nimotop administered continuously with an electric syringe pump), the label of the syringe (placed in the middle of the syringe) is wet and comes off.There was about 35ml of solution left in the syringe when this happened.Some air bubbles are also found in the tubing of the syringe, (neoline extension), connected to the patient.

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 28-feb-2022.H.6.Investigation: two samples received for investigation.One of the syringes was sent with a mating component connected to the luer thread.The other syringe was sent empty.Upon visual inspection of the samples no damage can be seen in the barrel of the syringes.Stopper is correctly assembled in both syringes.No leakage past the stopper can be detected in any of the samples as no liquid is seen between the ribs of the stopper.It is noticed there is a crack in the female luer component connected to the luer thread of the syringe, being the possible origin of the leakage noticed by customer.When liquid is expelled manually from the syringe, leakage though this part can be seen.Moreover, if there is a leak in any part of the system when the syringe is used in an electrical pump, air can enter to the closed system.Additionally, leak test is performed to verify the leakage defect described by customer is not related to a malfunction of the syringe.No leakage observed.A device history review was performed and found no non-conformances associated with this issue during the production of lot 2006226, all product was manufactured according to specification.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedure.Based on the quality team's investigation, a root cause related to our manufacturing process cannot be identified at this time.H3 other text : see h.10.

Event Description

It was reported that bd plastipak¿ 50ml concentric luer lock syringe experienced a case of leakage, and a case of air bubbles in the syringe.The following information was provided by the initial reporter: the service reports that the syringe has a leakage defect at the level of the barrel of the syringe, (the syringe is smooth and without visible defect).During use (treatment with nimotop administered continuously with an electric syringe pump), the label of the syringe (placed in the middle of the syringe) is wet and comes off.There was about 35ml of solution left in the syringe when this happened.Some air bubbles are also found in the tubing of the syringe, (neoline extension), connected to the patient.

• Brand Name: BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13005768
• MDR Text Key: 285476134
• Report Number: 3003152976-2021-00820
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300865
• Device Lot Number: 2006226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1